5 ms·

I've read over both sides of this, and there is some editorializing going on in this medical journal that makes it less about facts. The title makes no mention

I've read over both sides of this, and there is some editorializing going on in this medical journal that makes it less about facts. The title makes no mention of Ventavia, but instead mentions Pfizer. The headline doesn't specify that Ventavia managed 1/44th of the trial, nor anything factual (mostly speculation that the data integrity is questionable). > Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. The questions are all whether this one company had poor practices. It mixes comments regarding the larger trial of Pfizer with this isolated company trial. At times it's hard to tell if they're referencing Pfizer or Ventavia (as "company"). An investigation found nothing remarkable at other sites managed by other contractors, but then even that is questioned because this small company wasn't investigated. I'm not actually sure what part of this medical journal _is_ factual.

NoPie 5y ago
It was ultimately Pfizer's trial and Pfizer bears all responsibility for their contractors.
- angry_octet 5y ago
  What you’re saying is true, and completely tangential to the problem. When you are concerned that validation done by a subcontractor might be weak, it is entirely sensible that you subdivide the work. What we need is a statistical reanalysis that considers that, e.g., 10% of each step is done wrongly. And a regulatory regime that doesn’t hand wave away complaints, has rigorous protection for whistleblowers, and serious financial penalties for misconduct. The BMJ might be right, but also have constructed an article that will be wildly misunderstood... and not sensible content for facebook.
  - NoPie 5y ago
    It will not be misunderstood by intended readers of BMJ. As for facebook it has all kinds of readers and groups including those that are meant for professionals.
    - invisible 5y ago
      I think I completely understand the article but still think that it's editorializing facts. Why exactly would professionals feel differently? If they had done some investigations themselves and found a series of poor contractors that all reported similar issues, I think we could take this as much more concerning. This looks like a director from a single company and a few anonymous researchers at the same company came forward with bad practices for 1000 trials. Also, as the article points out, investigations were performed at other contractors. Wild speculation, but that could be that Pfizer didn't even need a full 44k and they just ignored 1k? (For example, they concluded the trial with 41k getting a second dose.)
      - NoPie 5y ago
        The issue is that proper investigation was not done. We need more transparency and this is not what is happening. What happened with the data from these researchers? There are no indications that they were removed from the study analysis. If the problems with this one researcher is swept under carpet, how do we know that there are not number of other researchers with different problems? Without this vigilance how do you distinguish between ivermectin studies that showed a positive effect and vaccine studies? Some of ivermectin studies but not all were discovered to be total frauds. At some point when you see too many problems you just have to distrust them by default until proved otherwise. In fact, I think that there is possibility that the Pfizer vaccine trial results turned out quite different from effectiveness in real life in part due to issues like this.
        srcreigh 5y ago
        The BMJ article, near the end, reports that the FDA actually did investigate and did find issues with the trial. > An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19. Of course, this comes after insinuating earlier that there is a complete lack of oversight. > “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. I guess since you yourself were misled according to their own inconsistencies, maybe that is enough to convince you that the article is misleading.
  - id02009 5y ago
    Not necessarily. If there's an instance of someone blowing the whistle, and there's no investigation it's completely reasonable to suspect that the whole integrity of the process might be iffy. Blocking the article (instead of opening relevant books to show that in fact it was just exception to otherwise solid prices makes) makes even stronger case that the prices is not honest.
DrHilarius 5y ago
> The questions are all whether this one company had poor practices. If the FDA did not follow up on the whistleblower report it raises far broader questions about oversight of the trials as a whole.
- sjtindell 5y ago
  There are so many foaming at the mouth morons desperate to “prove” that the whole thing was a sham that it will take extraordinary evidence to convince me anything improper was done.
  - NoPie 5y ago
    The solution is not to discredit BMJ but to explain how BMJ article doesn't mean what antivax is insinuating. I totally understand that when BMJ writes that this clinical research organization did a mess is this trial, someone misreads it as all Pfizer vaccine results are false. But if you say that BMJ is hoax, then we have much stronger reason to distrust healthcare professionals. Do you see the paradox here? BMJ is expressing concern about Pfizer and regulator's failures with the ultimate aim to fix them and increase the trust by showing that every fault is taken seriously. We cannot sweep unwanted things under the carpet and hope that nothing will happen. Bad actors should be appropriately punished.
  - mitigating 5y ago
    I want to second this. Because of how badly the right wants the vaccine to be dangerous/fake/whatever I'm so sensitive to anything negative that I basically brush off articles like this. In my mind I just lump it in with people saying the vaccine will make you impotent. Probably the wrong way to think about things but that's how my mind works.
srcreigh 5y ago
I guess it's not so hard to believe you're getting downvoted by shedding light on a situation about censorship. The first question in everybody's head when reading this article is, "Were the vaccine trials legitimate or not?" BMJ does not even come close to truthfully answering this question. With their authority as a medical journal and a very limited amount of evidence, they give a clear and incorrect impression that the vaccine trials were not legitimate. Do they report on the limitations of their evidence? No. Do they report on the perspective of employees at other trial sites? No. Do they get quotes from Pfizer, other health orgs, Ventavia executives? No. Do they report about other speculative factors at play from Ventavia ex-employees? No. Are they purposefully hiding new relevant information? Yes. They leaked in their own article that the FDA is aware and reviewed the Ventavia trial. > An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19. After insinuating earlier that there is a complete lack of oversight. > “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. Honestly, BMJ seems to be working very hard to lie using true facts. I have no objections to their articles being marked as false.
- NoPie 5y ago
  >> The first question in everybody's head when reading this article is, "Were the vaccine trials legitimate or not?" You are writing complete rubbish. BMJ does not question the legitimacy of the vaccine trials. With this sentence you are making very serious accusations to healthcare professionals. Most likely you don't even understand how clinical trials work or terminology used in the original article. If BMJ were not a serious journal, nothing in medicine would be serious including those trials. BMJ is questioning some irregularities brought to the light by a whistle-blower. It shows some evidence confirming issues about one particular clinical research organization and lack of reaction from the FDA. These issues should be addressed and resolved to remove doubts that the data from vaccine trials can be sufficiently trusted. Also FDA memorandum does not confirm that the FDA has investigated the sites. You probably don't even understand what the quoted professor meant by “oversight”. It definitely is not just checking and fully trusting the submitted paperwork.

NoPie 5y ago

It was ultimately Pfizer's trial and Pfizer bears all responsibility for their contractors.

angry_octet 5y ago
What you’re saying is true, and completely tangential to the problem. When you are concerned that validation done by a subcontractor might be weak, it is entirely sensible that you subdivide the work. What we need is a statistical reanalysis that considers that, e.g., 10% of each step is done wrongly. And a regulatory regime that doesn’t hand wave away complaints, has rigorous protection for whistleblowers, and serious financial penalties for misconduct. The BMJ might be right, but also have constructed an article that will be wildly misunderstood... and not sensible content for facebook.
- NoPie 5y ago
  It will not be misunderstood by intended readers of BMJ. As for facebook it has all kinds of readers and groups including those that are meant for professionals.
  - invisible 5y ago
    I think I completely understand the article but still think that it's editorializing facts. Why exactly would professionals feel differently? If they had done some investigations themselves and found a series of poor contractors that all reported similar issues, I think we could take this as much more concerning. This looks like a director from a single company and a few anonymous researchers at the same company came forward with bad practices for 1000 trials. Also, as the article points out, investigations were performed at other contractors. Wild speculation, but that could be that Pfizer didn't even need a full 44k and they just ignored 1k? (For example, they concluded the trial with 41k getting a second dose.)
    - NoPie 5y ago
      The issue is that proper investigation was not done. We need more transparency and this is not what is happening. What happened with the data from these researchers? There are no indications that they were removed from the study analysis. If the problems with this one researcher is swept under carpet, how do we know that there are not number of other researchers with different problems? Without this vigilance how do you distinguish between ivermectin studies that showed a positive effect and vaccine studies? Some of ivermectin studies but not all were discovered to be total frauds. At some point when you see too many problems you just have to distrust them by default until proved otherwise. In fact, I think that there is possibility that the Pfizer vaccine trial results turned out quite different from effectiveness in real life in part due to issues like this.
      - srcreigh 5y ago
        The BMJ article, near the end, reports that the FDA actually did investigate and did find issues with the trial. > An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19. Of course, this comes after insinuating earlier that there is a complete lack of oversight. > “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. I guess since you yourself were misled according to their own inconsistencies, maybe that is enough to convince you that the article is misleading.
- id02009 5y ago
  Not necessarily. If there's an instance of someone blowing the whistle, and there's no investigation it's completely reasonable to suspect that the whole integrity of the process might be iffy. Blocking the article (instead of opening relevant books to show that in fact it was just exception to otherwise solid prices makes) makes even stronger case that the prices is not honest.

DrHilarius 5y ago

> The questions are all whether this one company had poor practices. If the FDA did not follow up on the whistleblower report it raises far broader questions about oversight of the trials as a whole.

sjtindell 5y ago
There are so many foaming at the mouth morons desperate to “prove” that the whole thing was a sham that it will take extraordinary evidence to convince me anything improper was done.
- NoPie 5y ago
  The solution is not to discredit BMJ but to explain how BMJ article doesn't mean what antivax is insinuating. I totally understand that when BMJ writes that this clinical research organization did a mess is this trial, someone misreads it as all Pfizer vaccine results are false. But if you say that BMJ is hoax, then we have much stronger reason to distrust healthcare professionals. Do you see the paradox here? BMJ is expressing concern about Pfizer and regulator's failures with the ultimate aim to fix them and increase the trust by showing that every fault is taken seriously. We cannot sweep unwanted things under the carpet and hope that nothing will happen. Bad actors should be appropriately punished.
- mitigating 5y ago
  I want to second this. Because of how badly the right wants the vaccine to be dangerous/fake/whatever I'm so sensitive to anything negative that I basically brush off articles like this. In my mind I just lump it in with people saying the vaccine will make you impotent. Probably the wrong way to think about things but that's how my mind works.

srcreigh 5y ago

I guess it's not so hard to believe you're getting downvoted by shedding light on a situation about censorship. The first question in everybody's head when reading this article is, "Were the vaccine trials legitimate or not?" BMJ does not even come close to truthfully answering this question. With their authority as a medical journal and a very limited amount of evidence, they give a clear and incorrect impression that the vaccine trials were not legitimate. Do they report on the limitations of their evidence? No. Do they report on the perspective of employees at other trial sites? No. Do they get quotes from Pfizer, other health orgs, Ventavia executives? No. Do they report about other speculative factors at play from Ventavia ex-employees? No. Are they purposefully hiding new relevant information? Yes. They leaked in their own article that the FDA is aware and reviewed the Ventavia trial. > An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19. After insinuating earlier that there is a complete lack of oversight. > “There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials. Honestly, BMJ seems to be working very hard to lie using true facts. I have no objections to their articles being marked as false.

NoPie 5y ago
>> The first question in everybody's head when reading this article is, "Were the vaccine trials legitimate or not?" You are writing complete rubbish. BMJ does not question the legitimacy of the vaccine trials. With this sentence you are making very serious accusations to healthcare professionals. Most likely you don't even understand how clinical trials work or terminology used in the original article. If BMJ were not a serious journal, nothing in medicine would be serious including those trials. BMJ is questioning some irregularities brought to the light by a whistle-blower. It shows some evidence confirming issues about one particular clinical research organization and lack of reaction from the FDA. These issues should be addressed and resolved to remove doubts that the data from vaccine trials can be sufficiently trusted. Also FDA memorandum does not confirm that the FDA has investigated the sites. You probably don't even understand what the quoted professor meant by “oversight”. It definitely is not just checking and fully trusting the submitted paperwork.